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Baxter International

Global provider of medical care products

Quality Site Head

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeAibonito, Puerto RicoIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, or a related technical discipline is required; an advanced degree is preferred.
  • A minimum of 10 years of experience in Quality, Manufacturing, or related functions within the medical device, pharmaceutical, or healthcare products industry is required.
  • At least 7 years of progressive quality leadership experience is required, ideally within a global organization.
  • Strong knowledge of FDA regulations, Quality Systems, Good Manufacturing Practices (GMP), and regulatory compliance requirements is required.
  • Demonstrated success leading quality organizations in complex manufacturing environments is required.
  • Experience managing multiple priorities, driving results through ambiguity, and influencing cross-functional stakeholders is required.
  • A strong understanding of manufacturing processes, product configuration, and quality system methodologies is required.

Responsibilities

  • Provide overall leadership and governance for the site Quality Management System (QMS), ensuring requirements are effectively established, maintained, and continuously improved.
  • Serve as the site Quality Management Representative and ensure compliance with applicable regulatory, customer, and Baxter quality requirements.
  • Lead preparations for and management of regulatory inspections and external audits.
  • Establish, communicate, and monitor measurable quality objectives aligned with business and quality priorities.
  • Direct the planning, staffing, development, and budgeting of the site quality organization.
  • Ensure effective evaluation, management, communication, and documentation of product safety risks.
  • Maintain Good Manufacturing Practices (GMP) compliance across the site and oversee critical quality systems and processes.
  • Review and approve quality-related procedures, specifications, records, and product disposition decisions.
  • Lead management review activities and provide regular updates to senior leadership regarding quality system performance and improvement opportunities.

About the Company

Baxter International

Global provider of medical care products

Baxter International develops and manufactures medical products and equipment for hospitals and blood banks. Its products include sterile IV solutions and blood storage containers; innovations like the Transfuso-Vac extended blood shelf life, and a plastic blood bag helped shape modern blood banking. The company differs from competitors through a long track record of sterile manufacturing, blood-storage innovations, and strategic mergers that broaden its product portfolio. Its goal is to provide reliable, safe medical products that support patient care and hospital operations worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Deerfield, IL
Founded
1931

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